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Regulatory Operations Associate
Job summary
A leading clinical research organization is seeking a Regulatory Operations Associate to provide regulatory services for clients. Responsibilities include executing regulatory submissions, ensuring compliance, and collaborating with cross-functional teams. The ideal candidate should have a Bachelor’s degree in a related field and at least 2 years of experience in regulatory operations. The role offers a competitive salary and comprehensive benefits, emphasizing work-life balance and employee well-being.
Benefits
Qualifications
- Minimum of 2 years of experience in regulatory operations within the pharmaceutical or biotech industry.
- Strong attention to detail and organizational skills.
- Ability to work effectively in a team-oriented environment.
Responsibilities
- Execute publishing, compilation, filing, and maintenance of all global regulatory submission types.
- Ensure timely and accurate submission of regulatory documents.
- Partnership with cross-functional teams to facilitate regulatory activities.
- Maintain knowledge of regulatory requirements and guidelines.
- Contribute to process improvement initiatives within the Regulatory Operations group.
Skills
Education
Home based - CDMX
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Regulatory Operations Associate to join our diverse and dynamic team. As a Regulatory Operations Associate at ICON, you will play a pivotal role in providing comprehensive regulatory operations services for clients in compliance with applicable regulations, ICON’s Standard Operating Procedures, and project-specific operational alignments.
- Execute publishing, compilation, filing, and maintenance of all global regulatory submission types
- Ensure timely and accurate submission of regulatory documents
- Partnership with cross-functional teams to facilitate regulatory activities
- Maintain knowledge of regulatory requirements and guidelines
- Contribute to process improvement initiatives within the Regulatory Operations group
- Bachelor’s degree in a scientific or healthcare-related field
- Minimum of 2 years of experience in regulatory operations within the pharmaceutical or biotech industry
- Proficiency in regulatory submission software and tools
- Strong attention to detail and organizational skills
- Ability to work effectively in a team-oriented environment
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.